Quality Compliance Specialist

Masimo; Pasir Gudang; On-site; MYR 100,000 - 150,000; Full time

Job summary

An established industry player is seeking an Incoming Quality Engineer to ensure that all incoming materials meet rigorous quality standards. In this pivotal role, you will implement inspection processes, maintain documentation, and collaborate with suppliers to enhance material quality. Your analytical skills and attention to detail will be crucial in identifying areas for improvement and ensuring compliance with regulatory requirements. Join a dynamic team dedicated to operational excellence and quality assurance in a fast-paced manufacturing environment. If you are passionate about quality engineering and eager to make a significant impact, this role is an excellent opportunity for you.

Qualifications

• 3+ years of experience in Incoming Quality or related roles.
• Strong communication skills and analytical mindset required.

Responsibilities

• Conduct inspections of incoming materials to ensure quality standards.
• Collaborate with suppliers to address quality issues and improve processes.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Attention to Detail

Root Cause Analysis

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Measurement Tools

Job description

Job Summary:

An Incoming Quality Engineer plays a critical role in ensuring that incoming materials and components meet established quality standards and specifications. They are responsible for implementing processes and procedures to assess, inspect, and validate incoming materials for use in manufacturing processes. The role requires a combination of technical expertise, analytical skills, and a commitment to maintaining high standards of quality throughout the supply chain.

Duties & Responsibilities:

• Conduct thorough inspections of incoming materials and components to ensure they meet established quality standards, specifications, and regulatory requirements.
• Maintain accurate records of inspection results, test data, and any deviations from quality standards. Collect & maintain COC and all docs related to incoming material.
• Document non-conforming materials and initiate appropriate corrective actions.
• Collaborate with the supplier quality team to address quality issues, improve incoming material quality, and establish effective communication channels for resolving quality-related concerns.
• Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
• Ensure and monitor the applicable documents for Quality inspection are available in the point of use, including visual aids with physical samples.
• Continuously assess and improve incoming quality inspection processes to enhance efficiency, accuracy, and reliability. Identify opportunities for automation and optimization to streamline workflows.
• Provide training and guidance to employees involved in the incoming quality inspection process. Ensure that team members understand quality standards, inspection procedures, and best practices.
• Ensure that all Inspection Equipment that requires calibration is calibrated.
• Assist in Quality System activities such as following the PDA process, Internal Audits, Internal Observations, Document Control, and providing data for reports.
• Actively participate in continuous improvement initiatives aimed at enhancing overall product quality, customer satisfaction, and operational excellence.
• Any reasonable task assigned by Superior from time to time.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Minimum experience of 3 years in Incoming Quality.
• Good English communication skills, written and speaking.
• Previous experience in quality engineering, supplier quality management, or a related role within a manufacturing environment.
• Ability to perform measurement hands-on using simple hand tools, microscope, and Image measuring system.
• Excellent communication skills and the ability to collaborate effectively with internal and external teams.
• Analytical mindset with strong problem-solving skills and attention to detail.
• Experience with root cause analysis, corrective and preventive action (CAPA) processes, and risk management methodologies.

Preferred Qualifications:

• Proficiency in Microsoft Office knowledge.
• Experience in Risk Management to ISO 14971 and IEC 60601-1, 3rd Edition, ISO13485, and FDA regulations (will be added advantage).
• Strong knowledge of quality management principles, statistical analysis, and quality inspection techniques.
• Certified as an ISO internal auditor should be advantageous.

Education:

Bachelor’s degree in engineering is required and/or other related equivalent.

Physical requirements/Work Environment:

This position works in office, laboratory, and manufacturing environments. It requires frequent sitting, standing, and walking. The candidate needs to be able to recognize and differentiate color. They must also be able to lift up to 50 pounds. Daily use of computer and other computing and digital devices is required. The candidate may stand for extended periods when facilitating meetings, walking in the facilities, performing audits, and laboratory testing. The ability to operate a motor vehicle and maintain a valid driver license is required.

The physical demands of the position described herein are essential functions of the job, and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.